Commissioned Systems

Computer systems supplied by third parties (often known as system integrators) to specific user requirements should be validated entirely prospectively along the same lines that pharmaceutical and healthcare companies take for in-house developments. This, of course, requires that validation requirements are clearly identified and understood by the supplier at the outset of a project. 

The definition of supplier validation activities and documentation should be embedded in contractual agreements. In addition, suppfiers should agree to potential inspection by GxP regulatory agencies and Supplier Audit by pharmaceutical and healthcare companies. Supplier Audits can be conducted by the pharmaceutical or healthcare company s own personnel or, if this would compromise the supplier s commercial interests, by an independent software quality assurance auditor, consultant, or validation expert employed by the pharmaceutical or healthcare company. Auditors must be suitably qualified, for example by independent certification by examination to the quafity system standards such as ISO 9001 2000. Suppfier Audits are discussed in detail in Chapter 7. 

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Table 3.1 Major classes in the Enzyme Commission system for enzyme nomenclature...

A commissioning system with the true mechanical structure and prototype supply tubes was assembled before the construction of the final detector. In the commissioning system only two sectors were equipped with modules. A second test stand was established which allowed to operate the commissioning system independent of Systeml2. This test stand was later used to commission the two halves of the final detector system. The final detector system was tested sector-wise since only one sector could be connected to the readout at a time due to the limited number of optical fibers and FED modules available. 

On April 25, 2008 the commissioning system was shipped to CERN and a test installation took place. The system was craned down to the cavern through the main shaft, lifted to the installation table and inserted into CMS. The installation of the commissioning system went smoothly and was finished within less than 4h. The power cables and the optical fibers of fhe equipped sector were connected at the PPO and the correct cable lengths were verified. The installation test did not reveal any need for mechanical adjustment before the final installation. 

In conclusion, the costs of not commissioning exceed the costs of commissioning. Commissioning costs are best estimated based on the constmction costs of the commissioned systems 2 to 3 percent of mechanical construction costs and 1 to 2 percent of other systems costs. The cost of commissioning depends on the comnhssionmg approach used. Integrated commissioning offers an optimal mix of low cost, low potential for confhcts of interest, and low potential for project delay. 

Due to the complexity of the changes introduced to the system, a post commissioning system safety case update is submitted in order... 

This work, based on an innovative AE approach and instrumentation system, has been carried in the frame of the BRITE-EURAM Project 6056 "SIMON", with the financial support of the EU Commission. 

A manual entitled Reporting Physisorption Data for Gas/Solid Systems with Special Reference to the Determination of Surface Area and Porosity has been prepared as a provisional publication by Commission 1.6 of the International Union of Pure and Applied Chemistry (lUPAC). The purpose of the manual is to draw attention to problems involved in reporting physisorption data and to provide guidance on the evaluation and interpretation of isotherm data. The general conclusions and recommendations are very similar to those contained in Chapter 6. 

Committee on New Sensor Technologies Materials and Applications, National Materials Advisory Board, Commission on Engiueeriug and Technical Systems, National Kesearch Council Keport Expanding the Vision of Sensor Materials, National Academy Press, Washiagton, D.C. 1995, pp. 33-45. 

Alcohol Energy Systems Alcohol Elect One Test Report, Pub. 500—82—058, California Energy Commission, Sacramento, Calif., Aug. 1983. 

This was a great advance, as complex hydrocarbons of various kinds could be clearly named if their stmctures were known. The Geneva system, modified and expanded by subsequent Commissions, is used systematically in the fourth and fifth editions of Be /stem s Handbuch der Organischen Chemie (1), and as the basis of lUPAC nomenclature. In 1992 a commemorative symposium on the centennial anniversary of the Geneva Conference was held in Geneva (45). 

A technique called probabiUstic safety assessment (PSA) has been developed to analy2e complex systems and to aid in assuring safe nuclear power plant operation. PSA, which had its origin in a project sponsored by the U.S. Atomic Energy Commission, is a formali2ed identification of potential events and consequences lea ding to an estimate of risk of accident. Discovery of weaknesses in the plant allows for corrective action. 

Protection of the environment from uncontroHed radioactive release is also a consideration in the use of radiotracers. The quantity and concentration of radionucHdes that may be discharged into sewer systems is limited by regulations of the Nuclear Regulatory Commission (NRC). 

The Federal Trade Commission has aimounced a rule, effective November 30, 1995, that sets test procedures and labeling standards for recycled oil used as engine lubricating oil (35). The test procedures used are those contained in the Engine Oil Licensing and Certification System of the American Petroleum Institute (API) (36). The rule states in effect that if recycled oils meet the requirements of the API Certification System, such oils ate substantially equivalent to new oil for use as engine oil. This federal rule preempts certain state recycled oil rules (35). 

H. Lennartz and co-workers. Vaporisation Equilibrium of the Water—Sulfuric Acid System, Rep. Fur. 6783, Commission of European Communities, Hydrogen Energy Vector, Europe, 1980, pp. 60—70. 

The modem approach to wastewater treatment, protection of the oxygen resources of the receiving waters, requires that all aspects of the problem be addressed, ie, the systems approach. The Ohio River Sanitation Commission (ORSANCO) is an excellent example of basin-wide management dealing with situations that involve several poUtical entities. This approach has been adopted in several other regions. 

J. B. EusseU ia Generic Techniques in System KeliahilityAssessment, Office of Nuclear Regulatory Research, Nuclear Regulatory Commission, Washiagton, D.C., 1976. 

A system based partly on historical names, partly on the substrate, and partly on the type of reaction catalyzed is far from satisfactory. In 1956, the International Union of Biochemistry set up a Commission on Enzymes to consider the classification and nomenclature of enzymes. The Commission presented a report in 1961 whose recommendations for naming and classifying enzymes were subsequently adopted (12). Enzymes are classified on the basis of the reactions they catalyze. Despite its apparent complexities, the system is precise and very descriptive, accommodating existing enzymes and serving as a systematic basis for the naming of new enzymes. AH enzymes are placed in one of the six principal classes. 

Follow- Up. Even after the system is deHvered, additional work is usually needed. In conventional software engineering this is viewed as software maintenance or upgrade. It is referred to here as foUow-up to emphasize that the process of knowledge-base refinement that begias ia the prototypiag stage can continue even after the system is commissioned. The need for additional detail may come to light only after the appHcation has been ia use for some period of time. The time required to implement such enhancements should be takea iato accouat. 

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